Control of Immunological Veterinary Medicinal Products (OMCL)

On May 26, 1994, the European Union (EU) Commission and the Council of Europe decided to establish the Network of Official Medicines Control Laboratories (OMCL). This network performs activities related to pre- and post-marketing quality control of medicinal products used in humans and animals, ensuring the protection of public health and animal health. In European Union member states, the registration and marketing authorization of medicinal products and medical devices are directly linked to their quality, safety, and therapeutic efficacy. This activity is coordinated by the European Directorate for the Quality of Medicines (EDQM), subordinate to the Council of Europe.

National Veterinary Research Institute on January 16, 2017 obtained full member status in the Network of Official Medicines Control Laboratories (OMCL), within which it conducts quality control of immunological veterinary medicinal products through preliminary batch control and quality testing of immunological veterinary medicinal products.

Preliminary Batch Control of Immunological Veterinary Medicinal Products

The National Veterinary Research Institute – National Research Institute conducts preliminary batch control of immunological veterinary medicinal products (IVMP) in accordance with Article 128 of Regulation (EU) 2019/6 of the European Parliament and of the Council, issuing European OCABR/OBPR certificates.

Preliminary batch control of IVMP is conducted upon request from:

• the marketing authorization holder
• the representative of the marketing authorization holder
• the wholesale distributor
• the entity authorized for parallel import

Regarding the conduct of preliminary batch control of IVMP, two application purposes are distinguished:

• conducting preliminary batch control of IVMP for the purpose of:
  – issuing an opinion
  – issuing an OCABR certificate
  – issuing an OBPR certificate
• exemption from preliminary batch control of IVMP and issuing an opinion based on:
  – OCABR certificate
  – OBPR certificate

List of requirements for applicants requesting preliminary batch control of IVMP:

• delivery of IVMP sample – if preliminary batch control will be conducted based on quality testing of the product and completion of PO-07/F10
• completion of the application
• submission of the quality control certificate for the given IVMP batch or batch manufacturing report for the given IVMP batch issued by a qualified person
• submission of the marketing authorization for IVMP (if the previous one has expired)
• submission of an OCABR certificate – confirming the performance of preliminary batch control testing for the given IVMP batch, issued by the competent authorities in one of the European Union member states or European Free Trade Association (EFTA) member states or an OBPR certificate confirming the review of documentation containing quality test results for the given IVMP batch, issued by the authority of another European Union member state or European Free Trade Association (EFTA) member state – only in the case of an application whose purpose is exemption from preliminary batch control
• submission of the Marketing Information Form for the IVMP batch for which OCABR/OBPR was issued (on a form compliant with the current edition of EU Official Control Authority Batch Release, Official Batch Protocol Review Immunological Veterinary Medicinal Products) – only in the case of an application whose purpose is exemption from preliminary batch control

In cases where preliminary batch control will be conducted based on quality testing of IVMP and documentation review, the Applicant is required to submit a testing order together with the IVMP sample, application, and required documents to the Central Sample Reception Point (CPP).

In cases where preliminary batch control will be conducted based on documentation review, the Applicant is required to submit the application together with the required documents:

(1) via the eIWPL platform https://eiwpl.piwet.pulawy.pl/

Note: Access to the eIWPL platform can be obtained after prior contact with the Veterinary Medicinal Products Control Department. Applications submitted via the platform must be signed with a qualified electronic signature.

(2) electronically to the email address: ksw_iwpl@piwet.pulawy.pl

Note: The application must be signed with a qualified electronic signature. One email should contain data relating to one application, and the message subject should include the name and batch number of the IVMP.

(3) in paper form – in the absence of a qualified electronic signature.

Contact:
ksw_iwpl@piwet.pulawy.pl
tel. 81 889 32 97
tel. 81 889 31 40

Deadlines for Individual Stages of the Procedure

* deadline is counted from the date of delivery to NIVet-NRI of a complete application together with test samples (if applicable)

Quality Testing of Immunological Veterinary Medicinal Products

The National Veterinary Research Institute – National Research Institute conducts quality testing of immunological veterinary medicinal products as part of preliminary batch control of IVMP, national and European monitoring, as well as service testing, in accordance with the following list of testing procedures.

List of Testing Procedures